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Table 3 Mortality in trials of IVIG for proven sepsis & septic shock in adults and children

From: The INIS Study. International Neonatal Immunotherapy Study: non-specific intravenous immunoglobulin therapy for suspected or proven neonatal sepsis: an international, placebo controlled, multicentre randomised trial

Study

Exptl n/N

Ctrl n/N

Relative Risk (95% CI Fixed)

Weight

Standard IVIG vs placebo or no intervention, ACM

Chen 1996

2/28

1/28

2.00 [0.19, 20.82]

0.9%

De Simone 1988

7/12

9/12

0.78 [0.44, 1.39]

8.5%

Dominioni 1991

11/29

22/33

0.57 [0.34, 0.96]

19.3%

Grundmann 1988

15/24

19/22

0.72 [0.51, 1.03]

18.6%

Just 1986

6/13

9/16

0.82 [0.40, 1.70]

7.6%

Shenoi 1999

7/25

7/25

1.00 [0.41, 2.43]

6.6%

Weisman 1992

2/14

5/17

0.49 [0.11, 2.13]

4.2%

Subtotal

50/145

72/153

0.73 [0.57, 0.93]

65.8%

IgM-enriched IVIG vs placebo or no intervention, ACM

Erdem 1993

6/20

9/24

0.80 [0.34, 1.86]

7.7%

Haque 1988

1/30

6/30

0.17 [0.02, 1.30]

5.6%

Schedel 1991

2/27

9/28

0.23 [0.05, 0.97]

8.3%

Wesoly 1990

8/18

13/17

0.58 [0.33, 1.04]

12.6%

Subtotal

17/95

37/99

0.48 [0.30, 0.76]

34.2%

Total

67/240

109/252

0.64 [0.51, 0.80]

100%

  1. Review: Intravenous immunoglobulin for treating sepsis and septic shock
  2. Comparison: Polyclonal IVIG vs placebo or no intervention
  3. Outcome: All-cause mortality (ACM)